FDA drug recalls
The latest medications recalled in the U.S., straight from the FDA's openFDA Enforcement database — what was recalled, why, and how serious it is. Informational only; for any product you have, follow the FDA's guidance and ask your pharmacist.
Subscribe to the recall feed (RSS) — every new recall as it lands, with the FDA's own stated reason.
Recalls by drug type
CUROSURF (poractant alfa)
Class IILack of Assurance of Sterility
Chiesi USA, Inc. · Mar 17, 2026
Xanax XR, alprazolam, extended-release tablets, 3 mg, 60 bottles, Rx only…
Class IIFailed Dissolution Specifications
Viatris, Inc. · Mar 17, 2026
Octreotide Acetate for Injectable Suspension
Class IILack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Teva Pharmaceuticals USA, Inc · Mar 17, 2026
Albuterol Sulfate Inhalation Solution
Class IILabelling: Illegible label
Nephron SC, LLC · Mar 17, 2026
Octreotide Acetate for Injectable Suspension
Class IILack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Teva Pharmaceuticals USA, Inc · Mar 17, 2026
Octreotide Acetate for Injectable Suspension
Class IILack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Teva Pharmaceuticals USA, Inc · Mar 17, 2026
Cinacalcet Hydrochloride Tablets
Class IICGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Cipla USA, Inc. · Mar 16, 2026
Meclizine Hydrochloride Tablets
Class IIFailed tablet specifications.
Amerisource Health Services LLC · Mar 16, 2026
Cinacalcet Hydrochloride Tablets
Class IICGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Cipla USA, Inc. · Mar 16, 2026
Cinacalcet Hydrochloride Tablets
Class IICGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Cipla USA, Inc. · Mar 16, 2026
Lanreotide Injection
Class IILack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
Cipla USA, Inc. · Mar 13, 2026
Buprenorphine Hydrochloride
Class IICrystallization; identified as Buprenorphine free base
ENDO USA, Inc. · Mar 13, 2026
Lanreotide Injection
Class IILack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
Cipla USA, Inc. · Mar 13, 2026
0.9% Sodium Chloride Injection
Class IILack of Assurance of Sterility
Fresenius Kabi USA, LLC · Mar 11, 2026
0.9% Sodium Chloride Injection
Class IILack of Assurance of Sterility
Fresenius Kabi USA, LLC · Mar 11, 2026
0.9% Sodium Chloride Injection
Class IILack of Assurance of Sterility
Fresenius Kabi USA, LLC · Mar 11, 2026
0.9% Sodium Chloride Injection
Class IILack of Assurance of Sterility
Fresenius Kabi USA, LLC · Mar 11, 2026
0.9% Sodium Chloride Injection
Class IILack of Assurance of Sterility
Fresenius Kabi USA, LLC · Mar 11, 2026
5% Dextrose Injection
Class IILack of Assurance of Sterility
Fresenius Kabi USA, LLC · Mar 11, 2026
5% Dextrose Injection
Class IILack of Assurance of Sterility
Fresenius Kabi USA, LLC · Mar 11, 2026
5% Dextrose Injection
Class IILack of Assurance of Sterility
Fresenius Kabi USA, LLC · Mar 11, 2026
0.9% Sodium Chloride Injection
Class IILack of Assurance of Sterility
Fresenius Kabi USA, LLC · Mar 11, 2026
0.9% Sodium Chloride Injection
Class IILack of Assurance of Sterility
Fresenius Kabi USA, LLC · Mar 11, 2026
0.9% Sodium Chloride Injection
Class IILack of Assurance of Sterility
Fresenius Kabi USA, LLC · Mar 11, 2026
0.9% Sodium Chloride Injection
Class IILack of Assurance of Sterility
Fresenius Kabi USA, LLC · Mar 11, 2026
0.45% Sodium Chloride Injection
Class IILack of Assurance of Sterility
Fresenius Kabi USA, LLC · Mar 11, 2026
0.9% Sodium Chloride Injection
Class IILack of Assurance of Sterility
Fresenius Kabi USA, LLC · Mar 11, 2026
Icosapent Ethyl Capsules
Class IIFailed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
Zydus Pharmaceuticals (USA) Inc · Mar 9, 2026
Semaglutide-Glycine-Cyanocobalamin Injectable
Class IILack of Assurance of Sterility
PAYLESS COMPOUNDERS, LLC · Mar 6, 2026
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*
Class IILack of Assurance of Sterility
Apotex Corp. · Mar 5, 2026
HydroPeptide CLEAR ALLIANCE SERUM
Class IIChemical contamination: Presence of benzene
Owen Biosciences Inc. · Mar 3, 2026
STERILE EYE DROPS SOOTHING TEARS (polyethylene glycol 400 0.4% and propylene…
Class IILack of Assurance of Sterility
K.C. Pharmaceuticals, Inc · Mar 3, 2026
Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%
Class IILack of Assurance of Sterility
K.C. Pharmaceuticals, Inc · Mar 3, 2026
EYE DROPS Advanced Relief
Class IILack of Assurance of Sterility
K.C. Pharmaceuticals, Inc · Mar 3, 2026
SLMD Benzoyl Peroxide Acne Lotion
Class IIChemical contamination: Presence of benzene
Owen Biosciences Inc. · Mar 3, 2026
Sterile EYE DROPS REDNESS LUBRICANT (glycerin 0.25% and naphazoline HCl 0.012%)
Class IILack of Assurance of Sterility
K.C. Pharmaceuticals, Inc · Mar 3, 2026
Dry Eye Relief Drops
Class IILack of Assurance of Sterility
K.C. Pharmaceuticals, Inc · Mar 3, 2026
Sterile Eye Drops ORIGINAL FORMULA (tetrahydrozoline HCl 0.05%)
Class IILack of Assurance of Sterility
K.C. Pharmaceuticals, Inc · Mar 3, 2026
Ultra Lubricating Eye Drops (polyethylene 400 0.4%
Class IILack of Assurance of Sterility
K.C. Pharmaceuticals, Inc · Mar 3, 2026
SLMD BP Acne Spot Treatment
Class IIChemical contamination: Presence of benzene
Owen Biosciences Inc. · Mar 3, 2026
Showing 40 of 1,576 Class II recalls (1,895 tracked in total).
Related: which FDA-approved drugs are no longer marketed — our discontinued-drugs report →
What the recall classes mean
- Class I
- Most serious — a reasonable probability that use will cause serious harm or death.
- Class II
- May cause temporary or medically reversible harm; low probability of serious harm.
- Class III
- Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Data source: U.S. FDA openFDA Drug Enforcement Reports. This page reproduces FDA recall data for reference and is not medical advice. Always follow the FDA's and your pharmacist's guidance.